BLT vs Lidocaine for Procedural Pain

Overseen By Nardin Awad, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Anxiolytics, Opiates

Disqualifiers: Cardiac/respiratory disease, Seizure disorder, Neuropathies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.

Will I have to stop taking my current medications?

The trial requires that you stop taking anxiolytics (medications for anxiety) or opiates (pain medications) as they may interfere with the study results.

What data supports the effectiveness of the drug BLT (Benzocaine/Lidocaine/Tetracaine) for procedural pain?

Research shows that a cream containing lidocaine and tetracaine is effective in reducing pain during dermatologic procedures, such as laser treatments, and is associated with mild side effects. This suggests that the combination of these anesthetics in BLT could also be effective for procedural pain. ^{1 2 3 4 5}

Is the combination of lidocaine, benzocaine, and tetracaine safe for use in humans?

Research shows that lidocaine and tetracaine creams are generally safe for use in humans, with mild side effects. Studies on lidocaine creams, like LMX4, found no significant toxicity even when used in moderate amounts for cosmetic procedures. ^{1 2 3 6 7}

What makes the BLT drug unique for procedural pain?

The BLT drug, which combines benzocaine, lidocaine, and tetracaine, is unique because it offers a combination of three anesthetics that can provide effective pain relief with a shorter application time compared to some other topical anesthetics. This makes it particularly useful for quick procedures, as it can reduce waiting time for pain relief to take effect. ^{1 2 3 4 8}

Research Team

Brian J Simmons, MD

Principal Investigator

Dartmouth Health

Eligibility Criteria

This trial is for individuals experiencing pain during specific skin procedures like IPL (intense pulsed light), PDL (pulsed dye laser), and microneedling. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

I am between 18 and 75 years old.

I regularly see a dermatologist for skin treatments like IPL, PDL, or microneedling.

Exclusion Criteria

I am currently taking anxiety medication or painkillers.

I am currently pregnant or breastfeeding.

I am being treated for a skin condition that could affect this study's evaluation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical anesthetics (BLT and Lidocaine) applied to the face prior to IPL, PDL, and microneedling procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief effectiveness immediately after treatment

1 day

Treatment Details

Interventions

• BLT
• Lidocaine topical

Trial Overview The study aims to compare the effectiveness of a compounded anesthetic cream called BLT (Benzocaine/Lidocaine/Tetracaine) with a standard 4% Lidocaine cream in reducing pain from certain dermatological procedures.

Participant Groups

Group I: Left Side Lidocaine Experimental Treatment 2 Interventions

Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.

Group II: Left Side BLT Experimental Treatment 2 Interventions

Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.

BLT is already approved in United States, Canada for the following indications:

Approved in United States as BLT for:

• Pain relief during IPL, PDL, and microneedling procedures
• Minor burns and skin irritations
• Minor cuts and scrapes
• Itching

Approved in Canada as BLT for:

• Pain relief during IPL, PDL, and microneedling procedures
• Minor burns and skin irritations
• Minor cuts and scrapes
• Itching

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Findings from Research

The FDA-approved lidocaine and tetracaine topical anesthetic cream (Pliaglis®) is both safe and effective for managing pain during various dermatologic laser procedures, including laser resurfacing and hair removal.

Dermatologists should consider using LT cream as a preferred option for topical anesthesia to enhance patient comfort and satisfaction during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures. Cohen, JL.[2013]

Lidocaine/tetracaine cream (Pliaglis) is a newer topical anesthetic that effectively reduces pain during cosmetic dermatologic procedures, as shown in multiple clinical trials.

This combination anesthetic is favored for its ease of use and mild side effects compared to other topical anesthetics, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. Alster, T.[2021]

In a study involving 40 subjects undergoing superficial dermatosurgical procedures, the combination cream of 7% lignocaine and 7% tetracaine provided significantly better pain relief compared to the 2.5% lidocaine and 2.5% prilocaine cream, as measured by visual analogue scale scores.

The findings suggest that the lignocaine/tetracaine combination is an effective topical anesthetic for short-term use (30 minutes), allowing for quicker onset of analgesia and potentially improving the efficiency of dermatological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. Gahalaut, P., Mishra, N., Chauhan, S., et al.[2021]

In a study involving children aged 1-15 years, lidocaine-prilocaine cream was found to be significantly more effective than tetracaine 4% cream for pain relief during venipuncture, with 97% of patients receiving lidocaine-prilocaine reporting adequate pain relief compared to 76% for tetracaine.

Despite the statistical superiority of lidocaine-prilocaine, the clinical significance of the difference is minor, and tetracaine offers practical advantages such as a shorter application time, vasodilation effects, and lower cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. van Kan, HJ., Egberts, AC., Rijnvos, WP., et al.[2019]

A study involving 50 subjects with actinic keratosis showed that a self-occlusive topical anesthetic cream (7% lidocaine/7% tetracaine) significantly reduced pain during conventional photodynamic therapy (cPDT), with a 47% decrease in pain scores compared to a vehicle cream.

The lidocaine-tetracaine cream resulted in a median pain score reduction of 60%, demonstrating its effectiveness in making the cPDT procedure more tolerable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial"). Brumana, MB., Milani, M., Puviani, M.[2021]

Compound topical anesthetics, while potentially effective for dental procedures, are not FDA-regulated, raising significant safety concerns due to the risk of adverse reactions, including two reported deaths.

The FDA is increasing efforts to regulate these anesthetics, as some compounding pharmacies bypass the approval process, which ensures drugs are safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of compound topical anesthetics: a review. Kravitz, ND.[2019]

A study involving 8 healthy volunteers found that using 30 or 60 grams of occluded topical liposomal lidocaine (LMX4) for pain control in cosmetic procedures resulted in no significant absorption of lidocaine or its metabolites, indicating safety in these amounts.

Participants reported no systemic effects or clinical signs of lidocaine toxicity, supporting the conclusion that moderate use of 4% lidocaine cream is safe for dermatologic and cosmetic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of occluded 4% liposomal lidocaine cream. Nestor, MS.[2013]

In a study involving 44 children aged 4 to 10, lignocaine gel was found to have lower pain scores compared to benzocaine gel when used as a topical anesthetic before local anesthesia, although the differences were not statistically significant.

Both lignocaine and benzocaine were equally effective as topical anesthetics, but children preferred the taste of lignocaine over benzocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. Kotian, N., Mani, G., Ramakrishnan, M.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures. [2013]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. [2021]

3. Egypt pubmed.ncbi.nlm.nih.gov

Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial"). [2021]

6. England pubmed.ncbi.nlm.nih.gov

The use of compound topical anesthetics: a review. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of occluded 4% liposomal lidocaine cream. [2013]

8. India pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. [2022]